[Federal Register Volume 80, Number 161 (Thursday, August 20, 2015)]
[Notices]
[Pages 50638-50639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20557]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2768]


Collecting On-Farm Antimicrobial Use and Resistance Data; Public 
Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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    The Food and Drug Administration (FDA), in collaboration with the 
U.S. Department of Agriculture (USDA) and the Centers for Disease 
Control and Prevention (CDC), is announcing plans for a jointly 
sponsored public meeting to obtain public input on possible approaches 
for collecting additional on-farm antimicrobial drug use and resistance 
data. Such data are important for assessing the impact of measures 
being implemented to foster the judicious use of medically important 
antimicrobial drugs in food-producing animals.
    Date and Time: The public meeting will be held September 30, 2015, 
from 8 a.m. to 4:30 p.m. Although you can comment on the interagency 
plan for collecting on-farm antimicrobial drug use and resistance data 
at any time, to ensure that the Agencies consider your comment before 
updating this plan, submit either electronic or written comments by 
November 30, 2015.
    Location: The public meeting will be held in the USDA Jefferson 
Auditorium (South Building), 1400 Independence Avenue SW., Washington, 
DC 20250. Please arrive between 7 a.m. and 7:30 a.m. to provide time to 
get through security. Attendees must provide a valid government issued 
photo ID (Driver's License, Identification Card, or Passport) to enter 
the facility. Attendees should enter the building via Wing 5 on the 
Independence Avenue side of the building. The South Building is 
accessible by the Smithsonian Metro station (exit Metro station through 
the ``Independence Avenue Exit'' and walk toward 15th Street on 
Independence Avenue to reach Wing 5). For more information on 
directions and parking, visit http://smithsonianassociates.org/ticketing/help/locations/jefferson.htm.
    Contact Person: Kelly Covington, Center for Veterinary Medicine 
(HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 
20855, 240-402-5661, FAX: 240-276-9020, email: 
[email protected].
    Registration and Requests for Oral Presentations: Registration is 
required for this public meeting. Please send registration information 
(including name, title, organization, address, telephone and fax 
numbers) by email to [email protected] by September 18, 2015. 
There is no fee to register for the public meeting, and registration 
will be on a first-come, first-served basis. If you need special 
accommodations due to a disability, please contact Kelly Covington (see 
Contact Person) at least 7 days in advance.
    Oral presentations can be made by members of the public during the 
open public comment period of the public meeting. These presentations 
will be scheduled between approximately 3 p.m. and 4 p.m. on September 
30, 2015. Those persons desiring to make an oral presentation should 
notify the contact person listed in this notice by September 16, 2015, 
and submit a brief statement of the general nature of information they 
wish to present. In an effort to accommodate all who desire to speak, 
time allotted for each presentation may be limited. The contact person 
will inform each speaker prior to the meeting of the time they are 
scheduled to speak.
    Comments: Regardless of attendance at the public meeting, 
interested persons may submit either electronic comments to http://www.regulations.gov or written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, by (see Date and Time). It is only 
necessary to send one set of comments. Identify comments with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at http://www.regulations.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Antimicrobial drugs have been widely used in human and veterinary 
medicine for more than 50 years, with tremendous benefits to both human 
and animal health. The development of resistance to this important 
class of drugs, and the resulting loss of their effectiveness as 
antimicrobial therapies, poses a serious threat to public and animal 
health. Because antimicrobial drug use can contribute to the emergence 
of drug-resistant organisms, these important drugs must be used 
judiciously in both animal and human medicine to slow the development 
of resistance.
    In December 2013, FDA published Guidance for Industry (GFI) #213 
(http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf), which 
calls on animal drug sponsors of approved medically important 
antimicrobials administered through medicated feed or water to 
voluntarily remove production (growth promotion and feed efficiency) 
uses from their product labels, and bring the remaining therapeutic 
uses of these products (to treat, control, or prevent disease) under 
the oversight of a veterinarian by the end of December 2016. All 25 
affected drug sponsors have committed to implementing the changes 
described in GFI #213 by the December 2016 target date. Once the 
changes are fully implemented, it will be illegal to use these 
medically important antibiotics for production purposes, and animal 
producers will need to obtain authorization from a licensed 
veterinarian to use them for prevention, control, or treatment of a 
specifically identified disease.
    On March 27, 2015, the White House released the National Action 
Plan for Combating Antibiotic-resistant Bacteria (``National Action 
Plan'') (https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf). 
Developed in response to Executive Order 13676, which was issued by 
President Barack Obama on September 18, 2014, the National Action Plan 
is intended to guide the activities of the U.S. Government as well as 
the actions of public health, health care, and veterinary partners in a 
common effort to address the urgent and serious public health threat of 
drug-resistant bacterial infections. Objective 2.4 of the National 
Action Plan is to enhance monitoring of antibiotic resistance patterns, 
as well as antibiotic sales, usage, and management practices, at 
multiple points in the production chain for food animals and retail 
meat. The public meeting being announced in this Federal Register 
notice is consistent with Sub-Objective 2.4.3 of the National Action 
Plan, which calls for the USDA and FDA to seek public input on a plan 
for collecting drug use and resistance data on farms.
    In April 2015, USDA's Animal and Plant Health Inspection Service 
published an Info Sheet entitled ``Proposed Initiatives From the USDA 
Antimicrobial Resistance Action Plan'' (http://www.aphis.usda.gov/animal_health/nahms/amr/downloads/ProposedInitiatives.pdf). The Info 
Sheet provides a brief synopsis of initiatives

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proposed in the USDA Action plan, including a number of initiatives 
related to collecting on-farm antibiotic use and resistance data.
    Gathering information on the way medically important antimicrobials 
are used in food-producing animals is essential to measuring the impact 
of the FDA's GFI #213. FDA is collaborating with USDA and CDC to 
develop a plan for collecting additional on-farm data on antimicrobial 
use and resistance. Such data are intended to supplement existing 
information, including data on the quantity of antimicrobials sold or 
distributed for use in food-producing animals (reported under section 
105 of the Animal Drug User Fee Amendments of 2008) and data on 
antimicrobial resistance (e.g., collected under the National 
Antimicrobial Resistance Monitoring System and the National Animal 
Health Monitoring System). Data from multiple sources are needed to 
provide a comprehensive and science-based picture of antimicrobial drug 
use and resistance in animal agriculture.
    A data collection plan is needed to obtain additional information 
necessary to: (1) Assess the rate of adoption of changes outlined in 
the FDA's GFI #213; (2) help gauge the success of antibiotic 
stewardship efforts and guide their continued evolution and 
optimization; and (3) assess associations between antibiotic use 
practices and resistance. FDA is continuing to work with the USDA and 
CDC in developing this plan, and is holding this public meeting in 
order to obtain input from the public. This meeting is the first 
opportunity for public input as part of our ongoing effort to develop 
and implement plans for collecting additional on-farm antimicrobial 
drug use and resistance data.

II. Agenda

    The public meeting will provide an opportunity for public comment 
on possible approaches for collecting additional antimicrobial drug use 
data. The final agenda for the public meeting will be made available on 
the Agency's Web site at
    http://www.fda.gov/AnimalVeterinary/NewsEvents/WorkshopsConferencesMeetings/ucm456380.htm no later than 2 weeks prior 
to the meeting.

III. Transcript

    FDA will prepare a meeting transcript and make it available on the 
Agency's Web site (see section II) after the meeting. FDA anticipates 
that the transcript will be available approximately 60 business days 
after the meeting. A copy of the transcript will be available for 
public examination at the Division of Dockets Management (see Comments) 
between 9 a.m. and 4 p.m., Monday through Friday. In addition, copies 
of the transcript will be available in either hardcopy or on CD-ROM 
after submission of a Freedom of Information request. The Freedom of 
Information office address is available on the Agency's Web site at 
http://www.fda.gov.

    Dated: August 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20557 Filed 8-19-15; 8:45 am]
BILLING CODE 4164-01-P